A Phase 1 interventional study of Semaglutide Pen Injector in Scleroderma, Systemic, Fibrosis and Semaglutide, sponsored by Second Xiangya Hospital of Central South University. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-03-05.
Sponsored by Second Xiangya Hospital of Central South University · Phase 1, Interventional, and Treatment
This trial will study the safety and efficacy of subcutaneous semaglutide for the treatment of Systemic Sclerosis
Systemic Sclerosis (Ssc) is a rare, systemic autoimmune disease characterized by skin fibrosis and vasculopathy. In addition to the skin, it is a heterogeneous disease that affects multiple organs, including the cardiac, pulmonary, and gastrointestinal systems. This is a small prospective and open-label clinical trial of semaglutide in adults with systemic slceorsis. 10 systemic sclerosis patients will be recruited and receive semaglutide for 24 weeks. The primary endpoint of the study is the change in mRSS at 24 weeks of treatment.
610 studies on the registry are indexed under Scleroderma, Systemic; 218 are open to participants now.
This study's planned enrollment of 10 is below the median of 37 across 446 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →Second Xiangya Hospital of Central South University is the lead sponsor of 87 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:(Those who have not achieved good results after hormone or therapy)
Has received one or more of the following standard systemic treatments allowed by the research protocol:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive once-weekly semaglutide subcutaneous injection at escalating doses from 0.25 mg/week to 0.5 mg/week.
Drug: Semaglutide Pen Injector
Inject semaglutide subcutaneously once weekly, on the same day each week, at any time of day, in a dose increasing mode: the initial dose of 0.25mg QW (once a week), increased to 0.5mg QW after 4 weeks, and then maintained 0.5mg until the end of treatment in total 24 weeks.
Change in modified Rodnan skin score (mRSS) at week 24
Change in modified Rodnan skin score (mRSS) at week 24 performed by the same investigator at week 0 and week 24 and the change in mRSS will be calculated following the formula: ΔmRSS= mRSSw24 - mRSSw0. To measure mRSS, skin thickness of the patient is rated by palpation at each of 17 anatomic sites using a scale of 0-3 (0 = normal skin; 1= mild thickness; 2= moderate thickness; 3=severe thickness with an inability to pinch the skin into a fold). The scores at each site are summed with a minimum of 0 and a maximum of 51 (17 sites)
Time frame: Baseline and 24 weeks
Incidence of Adverse Events
Time frame: Baseline and 24 weeks
Incidence of Severe Adverse Events
Time frame: Baseline and 24 weeks
the scleroderma health assessment questionnaire-disability index (sHAQ-DI)
Time frame: Baseline and 24 weeks
High-resolution computer tomography (HRCT)
Time frame: Baseline and 24 weeks
Forced Vital Capacity(FVC) and Diffusing capacity of the lung for carbon monoxid(DLCO)
Time frame: Baseline and 24 weeks
St George' s Respiratory Questionnaire(SGRQ)
Time frame: Baseline and 24 weeks
Pulmonary arterial hypertension by echocardiography
Time frame: Baseline and 24 weeks
left ventricular ejection fraction by echocardiography
Time frame: Baseline and 24 weeks
6-Minute Walk Test (6MWT) Distance
Time frame: Baseline and 24 weeks
gastrointestinal tract (GIT) in scleroderma score
Time frame: Baseline and 24 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2024 (actual). Primary completion is estimated for Aug 2024, 6 months after the start.
Of 44 phase 1 interventional studies under Scleroderma, Systemic, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 60. This study's planned 6 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Semaglutide
Second Xiangya Hospital of Central South University